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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DK106511 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to conduct a prospective, longitudinal study to evaluate the usability of a patient-facing diabetes dashboard delivered via an established patient web portal.
Up to 70 adult patients with type 2 diabetes mellitus will be enrolled and given access to a diabetes dashboard within an existing patient web portal. Patients will be invited by mail (or email) to be screened for enrollment in the study. Patients may also respond at a study flyer and contact the study team to be screened for enrollment. Eligible and interested patients will be emailed a link to a secure study website where they will complete a web consent form. After enrollment, participants will complete a baseline web-based questionnaire. After completing the enrollment questionnaire, they will be provided access to the diabetes dashboard within the patient web portal for one month. After one month, participants will receive an additional follow-up (final) questionnaire to assess outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-facing Diabetes Dashboard | Other | The Patient-facing Diabetes Dashboard is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy level appropriate educational resources, and contains secure-messaging capability. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | The System Usability Scale (SUS) will be administered to all study participants at one month follow-up (T1). The SUS is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of "above average" usability. | one month follow-up (T1) |
| User Experience - Quantitative | User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). The survey items will inquire about participants' perspectives on particular features of the Patient-facing Diabetes Dashboard. Participants were asked to indicate which features, if any: (1) they found useful for managing their diabetes and which features, (2) improved their understanding of their diabetes health data, and (3) should be removed. In addition, participants indicated whether they intended to use the dashboard going forward if it remained available. | one month follow-up (T1) |
| User Experience - Qualitative | At the end of the study period (T1), a subset of study participants will be invited to complete a semi-structured interview to provide a deeper understanding of their experience using the dashboard. | one month follow-up (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| System Usage Data | This is a composite outcome measure of participants' self-reported total number of diabetes dashboard visits, total duration of dashboard use, use of embedded educational links, utilization of embedded functionality to secure message healthcare team member(s), and use of an embedded link to American Diabetes Association Online Community and will be queried at the end of the study period (T1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Martinez, MD, MS | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Martinez | Nashville | Tennessee | 37212 | United States |
Of the 69 enrolled participants, 67 completed the baseline questionnaire and were with given access to the intervention. Two participants never completed the baseline questionnaire despite reminders and therefore did not receive access to the intervention and were withdrawn.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
67 participants were provided access to the intervention, however, analysis was limited to 60 participants who completed the study (i.e., used the intervention and submitted both pre- and post-study questionnaires).
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability | The System Usability Scale (SUS) will be administered to all study participants at one month follow-up (T1). The SUS is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of "above average" usability. | All 60 participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires. | Posted | Median | Inter-Quartile Range | score on a scale | one month follow-up (T1) |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Martinez, MD | Vanderbilt University Medical Center | (615) 936-1010 | william.martinez@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2020 | May 7, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2018 | May 7, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| one month follow-up (T1) |
| Change in Diabetes Knowledge | The Short Diabetes Knowledge Instrument (SDKI) was used to measure diabetes knowledge including diabetes diet, symptoms of hypoglycemia, foot care and importance of physical activity. The SDKI is a 13-item scale with scores ranging from 0 to 13 representing number of items answered correctly. The Short Diabetes Knowledge Instrument (SDKI) will be administered to all study patients at enrollment (T0) and one month follow-up (T1). | enrollment (T0) and one month follow-up (T1) |
| Change in Diabetes Self-Care | Diabetes self-care will be measured using the Summary of Diabetes Self-Care Activities (SDSCA), an 11-item questionnaire of diabetes self-management that assess the following six aspects of the diabetes regimen: general diet (2 items), specific diet (2 items), exercise (2 items), blood-glucose testing (2 items), foot care (2 items), and smoking (1 items). Item responses use the metric "days per week" except for a single item about smoking status which is yes or no. Each of the five aspects (excluding smoking) is assigned a mean score based on number of days per week. The Summary of Diabetes Self-Care Activities (SDSCA) will be administered to all study patients at enrollment (T0) and one month follow-up (T1). | enrollment (T0) and one month follow-up (T1) |
| Change in Diabetes Self-Efficacy | The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. The PDSMS will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Eight items are scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. | enrollment (T0) and one month follow-up (T1) |
| Change in Diabetes Distress | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. | enrollment (T0) and one month follow-up (T1) |
| Change in Knowledge of Diabetes Measures | Unique study specific items to assess participants' knowledge of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants at enrollment (T0) and one month follow-up (T1). | enrollment (T0) and one month follow-up (T1) |
| Change in Diabetes Understanding | The Diabetes Care Profile (DCP) is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument includes sixteen scales. The Understanding Scale of the DCP contains 13 items that assesses respondents' perceived understanding of elements of diabetes self-care (e.g., diet for blood sugar control). We administered 9 of the 13 items to study participants, excluding items that referenced elements of self-management that are not covered in My Diabetes Care (e.g., pregnancy and diabetes). Respondents rate their understanding on a five-point Likert scale. The scale scores range from 1 to 5 and represents the average item score for the scale (∑ Q1-9/ Count of non-missing items). High scores indicate higher perceived understanding. | enrollment (T0) and one month follow-up (T1) |
| Change in Attitudes | Unique study specific survey items to assess participants' attitudes toward receiving social and goal-based comparison information regarding their diabetes health status will be administered to all study participants at enrollment (T0) and one month follow-up (T1). | enrollment (T0) and one month follow-up (T1) |
| Change in Patient Activation | The Patient Activation Measure® (PAM-13) scale will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The 13-item PAM® survey is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM® survey item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). | enrollment (T0) and one month follow-up (T1) |
| diagnosis changed from type 2 to type 1 |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Health Literacy | Health literacy was assessed using a validated one-item screener that asked respondents to rate their confidence independently filling out medical forms on a scale ranging from 'extremely' to 'not at all' confident. Consistent with prior studies, we categorized participants noting any lack of confidence filling out medical forms as having limited health literacy. | Count of Participants | Participants |
|
| eHealth Literacy | eHealth refers to healthcare services provided electronically via the Internet. eHealth Literacy refers to the knowledge, comfort, and perceived skill at finding, evaluating, and applying electronic health information to health problems. eHealth Literacy was assessed by the eHEALS scale which contains 8 items, measured with a 5-point Likert scale with response options ranging from "strongly disagree=1" to "strongly agree=5." Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy. | One participant did not complete the eHEALS scale | Mean | Standard Deviation | units on a scale |
|
| Patient Portal Usage | Count of Participants | Participants |
|
| Computer and Smartphone Usage | Participants could select more than one so totals may exceed 100%. | Number | participants |
|
| Hemoglobin A1c | Two participants were missing hemoglobin A1C data. | Mean | Standard Deviation | % |
|
| Insulin Use | Count of Participants | Participants |
|
| Time with diagnosis of diabetes | Mean | Standard Deviation | years |
|
| Comorbidities | Number of participants with comorbid hyperlipidemia and/or hypertension | Number | participants |
|
|
|
|
| Primary | User Experience - Quantitative | User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). The survey items will inquire about participants' perspectives on particular features of the Patient-facing Diabetes Dashboard. Participants were asked to indicate which features, if any: (1) they found useful for managing their diabetes and which features, (2) improved their understanding of their diabetes health data, and (3) should be removed. In addition, participants indicated whether they intended to use the dashboard going forward if it remained available. | Posted | Number | participants | one month follow-up (T1) |
|
|
|
| Primary | User Experience - Qualitative | At the end of the study period (T1), a subset of study participants will be invited to complete a semi-structured interview to provide a deeper understanding of their experience using the dashboard. | participants that participated in a semi-structured interview | Posted | Number | areas for improvement identified | one month follow-up (T1) |
|
|
|
| Secondary | System Usage Data | This is a composite outcome measure of participants' self-reported total number of diabetes dashboard visits, total duration of dashboard use, use of embedded educational links, utilization of embedded functionality to secure message healthcare team member(s), and use of an embedded link to American Diabetes Association Online Community and will be queried at the end of the study period (T1). | Posted | Count of Participants | Participants | one month follow-up (T1) |
|
|
|
| Secondary | Change in Diabetes Knowledge | The Short Diabetes Knowledge Instrument (SDKI) was used to measure diabetes knowledge including diabetes diet, symptoms of hypoglycemia, foot care and importance of physical activity. The SDKI is a 13-item scale with scores ranging from 0 to 13 representing number of items answered correctly. The Short Diabetes Knowledge Instrument (SDKI) will be administered to all study patients at enrollment (T0) and one month follow-up (T1). | Missing data for one participant | Posted | Median | Inter-Quartile Range | score on a scale | enrollment (T0) and one month follow-up (T1) |
|
|
|
|
| Secondary | Change in Diabetes Self-Care | Diabetes self-care will be measured using the Summary of Diabetes Self-Care Activities (SDSCA), an 11-item questionnaire of diabetes self-management that assess the following six aspects of the diabetes regimen: general diet (2 items), specific diet (2 items), exercise (2 items), blood-glucose testing (2 items), foot care (2 items), and smoking (1 items). Item responses use the metric "days per week" except for a single item about smoking status which is yes or no. Each of the five aspects (excluding smoking) is assigned a mean score based on number of days per week. The Summary of Diabetes Self-Care Activities (SDSCA) will be administered to all study patients at enrollment (T0) and one month follow-up (T1). | The overall number of participants analyzed for two blood-glucose testing items was 50, because 10 participants that do not test their blood sugar were excluded from those two items. Overall number of participants analyzed was 60 for the the other five aspects/sub-scales. | Posted | Median | Inter-Quartile Range | days per week | enrollment (T0) and one month follow-up (T1) |
|
|
|
|
| Secondary | Change in Diabetes Self-Efficacy | The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. The PDSMS will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Eight items are scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. | One participant had missing data. | Posted | Median | Inter-Quartile Range | score on a scale | enrollment (T0) and one month follow-up (T1) |
|
|
|
|
| Secondary | Change in Diabetes Distress | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. | Missing data for one participant. | Posted | Median | Inter-Quartile Range | score on a scale | enrollment (T0) and one month follow-up (T1) |
|
|
|
|
| Secondary | Change in Knowledge of Diabetes Measures | Unique study specific items to assess participants' knowledge of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants at enrollment (T0) and one month follow-up (T1). | As noted in the outcome measure data table below, the number analyzed for some items is less than 60 due to missing data. | Posted | Number | participants | enrollment (T0) and one month follow-up (T1) |
|
|
|
|
| Secondary | Change in Diabetes Understanding | The Diabetes Care Profile (DCP) is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument includes sixteen scales. The Understanding Scale of the DCP contains 13 items that assesses respondents' perceived understanding of elements of diabetes self-care (e.g., diet for blood sugar control). We administered 9 of the 13 items to study participants, excluding items that referenced elements of self-management that are not covered in My Diabetes Care (e.g., pregnancy and diabetes). Respondents rate their understanding on a five-point Likert scale. The scale scores range from 1 to 5 and represents the average item score for the scale (∑ Q1-9/ Count of non-missing items). High scores indicate higher perceived understanding. | Missing data for one participant | Posted | Median | Inter-Quartile Range | score on a scale | enrollment (T0) and one month follow-up (T1) |
|
|
|
|
| Secondary | Change in Attitudes | Unique study specific survey items to assess participants' attitudes toward receiving social and goal-based comparison information regarding their diabetes health status will be administered to all study participants at enrollment (T0) and one month follow-up (T1). | Posted | Number | participants | enrollment (T0) and one month follow-up (T1) |
|
|
|
|
| Secondary | Change in Patient Activation | The Patient Activation Measure® (PAM-13) scale will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The 13-item PAM® survey is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM® survey item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). | Posted | Median | Inter-Quartile Range | score on a scale | enrollment (T0) and one month follow-up (T1) |
|
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
Not provided
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| Title | Measurements |
|---|---|
|
| Patients Like Me Data - useful |
|
| Literacy Sensitive Education Links - useful |
|
| Diabetes Online Community - useful |
|
| Star Status Indicator - understanding |
|
| Hover Over Info Icons - understanding |
|
| Goal, Caution, and Warning Ranges - understanding |
|
| Literacy Sensitive Education Links - understanding |
|
| Diabetes Online Community - understanding |
|
| Star Status Indicator - removed |
|
| Hover Over Info Icons - removed |
|
| Goal, Caution, and Warning Ranges - removed |
|
| Patients Like Me Data - removed |
|
| Literacy Sensitive Education Links - removed |
|
| Diabetes Online Community - removed |
|
| Intend to use going forward |
|
| Title | Measurements |
|---|---|
|
| Total number of visits: 7+ |
|
| Total minutes spent: <5 minutes |
|
| Total minutes spent: 5-9 minutes |
|
| Total minutes spent: 10-14 minutes |
|
| Total minutes spent: 15+ minutes |
|
| Used literacy sensitive education links |
|
| Used secure messaging |
|
| Used diabetes online community |
|
| Used info icon with explanation of health measure |
|
|
| specific diet at enrollment (T0) |
|
|
| specific diet at one month follow-up (T1) |
|
|
| exercise at enrollment (T0) |
|
|
| exercise at one month follow-up (T1) |
|
|
| blood-glucose testing at enrollment (T0) |
|
|
| blood-glucose testing at one month follow-up (T1) |
|
|
| foot care at enrollment (T0) |
|
|
| foot care at one month follow-up (T1) |
|
|
| 0.13 |
| Other |
| Analysis for pre-post change in Exercise sub-scale score | Wilcoxon Signed Rank Sum test | 0.35 | Other |
| Analysis for pre-post change in Blood-glucose Testing sub-scale score | Wilcoxon Signed Rank Sum test | 0.67 | Other |
| Analysis for pre-post change in Foot Care sub-scale score | Wilcoxon Signed Rank Sum test | 0.65 | Other |
|
| Identify goal range for A1c at T0 |
|
|
| Identify goal range for A1c at T1 |
|
|
| Identify definition of blood pressure at T0 |
|
|
| Identify definition of blood pressure at T1 |
|
|
| Identify goal range for blood pressure at T0 |
|
|
| Identify goal range for blood pressure at T1 |
|
|
| Identify definition of LDL cholesterol at T0 |
|
|
| Identify definition of LDL cholesterol at T1 |
|
|
| Identify goal range for LDL cholesterol at T0 |
|
|
| Identify goal range for LDL cholesterol at T1 |
|
|
| Identify definition of flu vaccine at T0 |
|
|
| Identify definition of flu vaccine at T1 |
|
|
| Identify frequency of flu vaccination at T0 |
|
|
| Identify frequency of flu vaccination at T1 |
|
|
| 1.00 |
| Other |
| Analysis for pre-post change in knowledge of definition of systolic blood pressure | McNemar | 0.63 | Other |
| Analysis of pre-post change in knowledge of goal range for systolic blood pressure | McNemar | 0.02 | Other |
| Analysis of pre-post change in knowledge of definition of LDL cholesterol | McNemar | 0.55 | Other |
| Analysis for pre-post change in knowledge of goal range for LDL cholesterol | McNemar | 0.0009 | Other |
| Analysis of pre-post change in knowledge of definition of flu vaccine | McNemar | 1.00 | Other |
| Analysis of pre-post change in knowledge of recommended frequency of flu vaccination | McNemar | 1.00 | Other |
| Title | Measurements |
|---|---|
|
| Interested goal-based comparison info at T1 |
|
| Agree social comparison info is useful at T0 |
|
| Agree social comparison info is useful at T1 |
|
| Agree goal-based comparison info is useful at T0 |
|
| Agree goal-based comparison info is useful at T1 |
|
| McNemar |
| 1.00 |
| Other |
| Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me [social comparison information] is useful.' | McNemar | 0.51 | Other |
| Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range [goal-based comparison information] is useful. | McNemar | 0.63 | Other |